TRYPTAN TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

TRYPTOPHAN

Dostępny od:

BAUSCH HEALTH, CANADA INC.

Kod ATC:

N06AX02

INN (International Nazwa):

TRYPTOPHAN

Dawkowanie:

750MG

Forma farmaceutyczna:

TABLET

Skład:

TRYPTOPHAN 750MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

MISCELLANEOUS ANTIDEPRESSANTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0111038005; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2021-06-11

Charakterystyka produktu

_Pr_
_TRYPTAN_
_®_
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TRYPTAN
®
L-Tryptophan
250 mg; 500 mg; 750 mg tablets
1 g Tablets
500 mg Capsules
Oral
Adjunct in the Management of Affective Disorders
Bausch Health, Canada Inc.
Date of Initial Authorization:
2150 St-Elzear Blvd. West
February 23, 1994
Laval, Quebec
H7L 4A8
Date of Revision:
June 9, 2021
Submission Control Number: 247785
_ _
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_TRYPTAN_
_®_
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RECENT MAJOR LABEL CHANGES
NONE
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT
LISTED.
RECENT MAJOR LABEL CHANGES
....................................................................................
2
TABLE OF CONTENTS
.........................................................................................................
2
PART I: HEALTH PROFESSIONAL
INFORMATION..............................................................
4
1
INDICATIONS.............................................................................................................
4
2
CONTRAINDICATIONS
..............................................................................................
4
4
DOSAGE AND ADMINISTRATION
.............................................................................
4
4.2
Recommended Dose and Dosage Adjustment
................................................... 4
4.4
Administration....................................................................................................
4
5
OVERDOSAGE
..........................................................................................................
5
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
....................... 5
7
WARNINGS AND PRECAUTIONS
.............................................................................
6
8
ADVERSE REACTIONS
.............................................................................................
7
8.1
Adverse Reaction Overview
.............